SYNCHRON® Controls are made from stabilized human serum and are designed to monitor the performance of SYNCHRON Systems in the clinical laboratory. SYNCHRON Control levels, 1, 2, and 3 bear a quantitative relationship to each other; Level 2 is manufactured by combining equal quantities of levels 1 and 3. The use of three levels enable the laboratorian to monitor changes in calibration and linearity along with analytical error and imprecision.

Device Description

The SYNCHRON® Control kit consists of three levels of controls (Level 2, and Level 3) for use on the SYNCHRON Systems. There are a total of 6 bottles (two 20-mL bottles per level). SYNCHRON® Controls are made from stabilized human serum and are designed to "monitor" the "performance" of SYNCHRON Systems in the clinical laboratory. The controls are made of frozen human plasma that has been defibrinated and, then, it is stabilized with ethylene glycol.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "SYNCHRON® Control". This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than detailing a specific clinical study with acceptance criteria and performance metrics typically found in clinical trial reports for device efficacy or diagnostic accuracy.

Therefore, many of the requested sections about clinical study details cannot be fully answered from the provided text.

Here is an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical thresholds for a specific performance study. Instead, it relies on demonstrating stability and substantial equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Stability claim of 18 months	Stress stability studies of the SYNCHRON® Control support the stability claim of 18 months.
Substantial Equivalence to Predicate	The modified SYNCHRON® Control contains vancomycin and the current product does not. This change is considered to maintain substantial equivalence.

Note: The nature of this device (Quality Control Material) means that "performance" refers to its stability and its ability to consistently monitor the performance of diagnostic systems (SYNCHRON Systems), rather than direct diagnostic accuracy of a patient's condition.

Study Details

Sample size used for the test set and the data provenance:
- The document mentions "Stress stability studies" but does not specify the sample size (e.g., number of control lots, number of measurements per lot) used in these studies, nor does it detail the data provenance (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a quality control material used to monitor analytical systems, not a diagnostic device that requires expert interpretation of results to establish ground truth for a test set. The "ground truth" for a control material would be its known target values, established by the manufacturer, against which the system's measurements are compared.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in studies involving human interpretation of data where consensus on ground truth is critical (e.g., image reading). This is not relevant for a stability study of a quality control material.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic device, nor is it a device where human reader performance is being evaluated.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical quality control material, not an algorithm. Its "performance" is its intrinsic stability and its reference values for analytical systems.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a quality control material, the "ground truth" would be the assigned target values and their acceptable ranges, established during the manufacturing and characterization process of the control material itself. These values are determined through rigorous analytical testing and standardization, not typically through pathology or expert consensus on clinical cases. The document implies that the "SYNCHRON Control levels, 1, 2, and 3 bear a quantitative relationship to each other" and are designed to monitor analytical performance.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI-based device that requires a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.

In summary: The provided 510(k) summary focuses on regulatory approval based on stability and substantial equivalence to a predicate device, rather than a clinical study evaluating diagnostic performance. As such, many of the requested details concerning human readers, AI, and ground truth establishment in a diagnostic context are not relevant or present in this document.

Summary

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K013235

510(k) Summary SYNCHRON® Control

Submitted By: 1.0

Mary Beth Tang Mary Both Sale Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123

OCT 1 6 2001

Date Submitted: 2.0

September 26, 2001

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Control

Classification Name 3.2

Quality Control Material (21 CFR §862.1660)

Predicate Device(s): 4.0

SYNCHRON SystemsReagent	Predicate	Manufacturer	DocketNumber
SYNCHRON® Control	SYNCHRON® Control	Beckman Coulter, Inc.	K003488

5.0 Description:

The SYNCHRON® Control kit consists of three levels of controls (Level 2, and The SYNCHRON® Control KE consiste of three free are a total of 6 bottles (two 20-mL
Level 3) for use on the SYNCHRON Systems. There free are a total of 6 bottles (two 20-mL Level 3) for use on the STNCHRON® Controls are made from stabilized human serum and bottles perferen. STNOrth of control and most of SYNCHRON Systems in the clinical are designed to "monitor" the "personnance" of of frozen human plasma that has been defibrinated and, then, it is stabilized with ethylene glycol.

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6.0 Intended Use:

Comparison to Predicate(s): 7.0

The modified SYNCHRON Control claims substantial equivalence to the SYNCHRON Control currently in commercial distribution (K003488). The modified SYNCHRON Control contains vancomycin and the current product does not.

8.0 Summary of Performance Data:

Stress stability studies of the SYNCHRON Control support the stability claim of 18 months.

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 6 2001

Ms. Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard M/S W-104 Box 8000 Brea, California 92822-8000

Re: K013235

Trade/Device Name: SYNCHRON® Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I, reserved Product Code: JJY Dated: September 26, 2001 Received: September 28, 2001

Dear Ms. Tang:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to commerce price to May 20, 1978, ins casordance with the provisions of the Federal Food, Drug, devices that have been resuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, manov and include requirements for annual registration, listing of general controls provisions of aactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassinod (600 a00 rols. Existing major regulations affecting your device can may or subject to back acceler as egulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I house of actived that I Drivice and that your device complies with other requirements of the Act that I Drines intatutes and regulations administered by other Federal agencies. You must or any I odolar statuation and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF I rat 007); adoling (2 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quanty byevelle (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notheation. The I Drice results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 IT you desire specific arrive for fist assic devices), please contact the Office of Compliance at additionally 607.10 for in the examplestions on the promotion and advertising of your device, (201) 594-4568. Routlonally, 10. quese at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionates and er Assistance at its toll-free number (800) 638-2041 or 1301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

page_1_of_1_

510(k) Number (if known): Not yet assigned KO13235

SYNCHRON® Control Device Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Kesia Alexander for Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use (per 21 CFR 801.109) OR

Over-the-Counter Use Optional Format 1-2-96

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.